| Methods |
2‐arm active‐controlled double‐blinded randomised trial |
| Participants |
461 women were randomised in a hospital setting in the UK. The population comprised women of unspecified parity, either singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing elective caesarean section, or those with significant hypertension or cardiac disease. |
| Interventions |
500 mcg plus 5 IU of ergometrine plus oxytocin administered IM versus 5 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; manual removal of placenta; blood loss (mL); third stage duration (minutes). |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Unclear sequence: described as without any blocking or stratification. |
| Allocation concealment (selection bias) |
Low risk |
Used identical study boxes prepared by third party (Sandoz). |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Study participants and caregivers were blinded to treatment allocations. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
High risk |
Investigators appraised blood loss quote: "in the standard way by graduated jug measurement plus an allowance for spillage". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data were collected completely from all randomised study participants. |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
Low risk |
All those who were enrolled and randomly allocated to treatment were included in the analysis, in the groups to which they were randomised. |
| Funding source |
Low risk |
The study was supported by funding from the Perinatal Trials Service (public funding), for the Department of Health for England and Wales, and for Birthright (the charitable arm of the RCOG). Coded medication ampoules were provided by Sandoz. |
